FDA Update

PATIENT LABELING for HUMAN Rx and Biological Products

Patients and Caregivers Alike Can Finally Rely on Clear Usage Instructions for Prescription and Biological Drugs as the

FDA Issues Final Guidance on Instructions for Use Documents

The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.”

The Instructions for Use (IFU) document is written for patients or their caregivers who use prescription drug and biological products that have complicated or detailed instructions. The recommendations in this guidance are intended to help provide consistency to the content and format of IFU documents and to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products.

This guidance finalizes the draft guidance that FDA issued in July 2019 titled “Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format, Guidance for Industry.” In the final guidance, FDA added clarifying language, consolidated discussions of human factors, and aligned the final guidance with the standards used in other Center for Drug Evaluation and Research policy documents.

This final guidance is a commitment included in the Prescription Drug User Fee Act (PDUFA) VI performance goals letter related to guidance on patient-oriented labeling (e.g., IFU documents).

For more information on Instructions for Use Documents, please email us at: info@mdiconsultants.com and ref: Instructions for Use Documents.